Mesh surgery consequences borne by women

ON March 12 the Newcastle Herald ran five pages of articles headed “Suffer in Silence: How women have been caught up in a medical disaster”.

The phone calls and emails from women have not stopped since then, from as far away as the United Kingdom and America, from the Hunter and across Australia.

Many were women who believed they were alone in dealing with the devastating consequences of transvaginal mesh surgery, when the “known complications” of that surgery occurred.

Devastated: Women want a full inquiry into how mesh devices were approved for the Australian market.

Others were like Caz Chisholm, who talked about her mesh surgery complications on a Facebook page in late 2014, and eventually established the Australian Pelvic Mesh Support Group because of the response.

The stories from women were very similar, regardless of which Australian state, or even which country, they lived in. They had prolapse problems – the weakening of pelvic muscles and ligaments, mainly after pregnancy, birth or hysterectomy.

Their doctors advised that surgery through the vagina to implant supportive mesh for the weakened muscles and ligaments would give relatively simple and quick results.

There is no doubt that was the case for many Australian women. How many is not clear, after the federal Department of Health advised on Wednesday that mesh devices are not funded by Medicare, so do not appear in federal health statistics, but are funded by state governments and private health insurers.

The number of women officially suffering adverse events from mesh surgery is clearly under-reported, which is an issue that needs to be addressed all on its own. Some women have complained to the NSW Health Care Complaints Commission alleging their doctors failed to fully inform them of the risks with mesh surgery.

Less than a handful have been aware that mesh, being a device, comes under the Australian Therapeutic Goods Administration. The TGA registered the first devices in 2004 and 2005 with no evidence of their safety and efficacy for use in prolapse surgery, and with clear warnings about the lack of controlled clinical trials for the related mesh devices used to piggy-back transvaginal prolapse mesh onto the Australian market.

Mesh manufacturers are required to report adverse events to the TGA, if they’re aware of them. Doctors aren’t. This left a vacuum where some women were suffering extraordinary, life-altering consequences, and doing so in silence, while the one or two who did establish they could complain to the TGA were told their problems were rare because they were the first to complain.

I have seen the “evidence” relied on by the TGA to register the earliest transvaginal mesh devices for prolapse surgery. The TGA conceded in 2014 that its mesh assessment process a decade ago was not “mature” and lacked “rigour”.

We’re entitled to know why.

The medical fraternity does not come out of this well, either. Too many doctors I’ve approached for comment have declined. Complaints to regulators have taken years, and in those years more women have had surgery for mesh which has left them with permanent, and appalling consequences.

There needs to be a formal inquiry into how this happened – how manufacturers aggressively marketed devices for years, gained responsibility to train doctors, and when women complained they were not taken seriously, until it was too late.